Speakers & Moderators

Sander van den BanGSK, Hertfordshire, UKSander van den Ban is a technical director in GlaxoSmithKline and worked in the Pharmaceutical Industry for over 10 years in various positions as Chemical Process Engineer in Research and Development, Engineering Technology and Capital Management, Process Design and Development and Solid Dose Centre of Excellence. In his current role as a Product Lead in the Oral Solid Dose Centre of Excellence he is accountable for the technical transfer and introduction of well understood reliable manufacturing processes for tablet dosage forms into manufacturing with particular focus on QbD and interaction with US, European and International regulatory agencies.

Fiona ClarkePfizer Ltd., Sandwich, Kent, UKFiona Clarke is currently Director of Material Characterisation within Pfizer’s Global Supply organisation. Under her leadership this group has grown over the past 15 years from one focused on the deconstruction of tablet matrices for problem solving to the group which today provides advanced understanding of material attributes and their impact to final product performance across all business units. She has a BSc (Hons) in Forensic and Analytical Chemistry from the University of Strathclyde and a PhD in Pharmaceutical Analysis from the London School of Pharmacy.

Dr Øyvind Holte Norwegian Medicines Agency Øyvind Holte is a scientific officer at the Norwegian Medicines Agency. His main activities are the assessment of applications for new drug products and variations to existing products, mainly chemical drug products. He is a member of the EDQM PAT working party, and was involved in the elaboration of the recently published Ph.Eur. chapter 2.9.47 ‘Uniformity of dosage units using large sample sizes’. He is a member of the EMA PAT team. The PAT team provides general regulatory guidance in relation to PAT/QbD and specific guidance to applicants.

Dr Ajaz HussainInsight, Advice & Solutions, LLC, USADr. Ajaz Hussain’s career at US FDA spanned 10 years; form 2000-2005 he served as the Deputy Director of the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER), FDA and held a "peer reviewed" Senior Biomedical Research position in the US Government Service. Ajaz is now a management consultant for lifesience sector. During his industrial career he has built teams to develop and launch several fist-in class complex generic and biosimilar products, contributed to advancing plant based vaccines and development of evidence necessary to demonstrate tobacco harm reduction.

Dr Peter McDonnellSanofi, Paris, FrancePeter graduated with a PhD in physical organic chemistry in 1985 and has worked in been working in the Pharma industry since then, primarily in development, but also in medicinal chemistry. Since joining Genzyme (now Sanofi) 20 years ago, he has worked across many platforms including API (small molecule, biologics, polymers) and dosage forms. He has recently accepted the position of Global Innovation Strategy and External partnership Manager for the Development function of Sanofi based in Paris.

Karthik IyerFDA, CDER, USA (via video conference)Karthik Iyer (ASQ CSSBB, CQE) works as a senior policy advisor in FDA/CDER/OC/OMPQ. His main responsibilities are to support both CDER and ORA with respect to CGMP manufacturing statistics (sampling, statistical process control, process validation, use of statistical consensus standards). His prior experiences include refining, chemical, and consumer products industries with an emphasis on manufacturing statistics. He has a BS in Chemical Engineering from the University of Illinois, an MBA from the University of Iowa , and a MS in Biosciences Regulatory Affairs from Johns Hopkins University respectively.

Dr Peter PoechlauerDSM, AustriaPeter Poechlauer received a PhD in organic chemistry from Innsbruck University in 1986. 2 years of post-doc studies at Munich University in the Laboratories of Prof. Rolf Huisgen followed. Both activities were dedicated to the elucidation of organic reaction pathways. In 1990 he joined Chemie Linz, later OMV, as a synthetic chemist. Since 1996 he has worked with DSM as scientist, project leader and competence manager. 2003 – 2007 he headed a department of process technology. Since 2007 he has worked as principal scientist with a focus on process intensification and micro reactor technology. Since 2014 he has been responsible for Innovation Management.

Dr Gabriele ReichFaculty of Biological Sciences, University of HeidelbergGabriele Reich is Senior Lecturer for Pharmaceutical Technology and Biopharmaceutics at the Institute of Pharmacy and Molecular Biotechnology (IPMB), Faculty of Biological Sciences, University of Heidelberg and Research Group Leader at IPMB / Department of Pharmaceutical Technology and Biopharmaceutics.

Justin PritchardVertex, USAJustin Pritchard is a Scientist in Process Analytical Technology at Vertex Pharmaceuticals Incorporated. Justin has been responsible for the development, implementation, and validation of PAT methods for continuous manufacturing. His background in spectroscopy, solid state analysis and traditional separations science provides broad analytical experience for his current role as a PAT practitioner. Justin also currently serves on the Steering Committee for PPAR (Pharmaceutical Process Analytical Roundtable).